Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
What we offer:
As part of a pharmaceutical laboratory recognized in its field, you will be responsible for :
– Data cleansing, queries and action plan management
– Coordination and management of clinical data reviews with the project team
– Validate data transfers and reconcile external data with the clinical database.
– Ensure reconciliation with the pharmacovigilance database (listings, meetings, etc.) in collaboration with the clinical and pharmacovigilance teams, and manage the actions for which you are responsible.
– Monitor data coding activities and supervise subcontracting (communication and validation of invoices)
– Management of eCRF user access (periodic review)
– Coordinate the freezing of the clinical database and draft the Data Management Report for frozen studies
– Ensure the constitution of the TMF data management section
– Ensure compliance with study schedules for data management.
– Participate in study meetings and report to the clinical project manager on the progress of data management for the studies for which you are responsible.
– Participate in validation tests (design, programming, UAT).
Minimum Requirements :
– Data Manager with knowledge of SAS (minimum 2 years’ experience)
– Mastery of databases, data management tools (EDC Merative is a plus) and regulatory frameworks
– Rigor, responsiveness, precision, autonomy, dynamism, ability to work in a team.
– Ability to communicate with various stakeholders
– Fluency in spoken and written English, ability to communicate in English in meetings or teleconferences¬.
The Position is located in Paris Area